An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability and pharmacodynamics after a single intranasal dose of BPL-003 combined with psychological support, in patients with treatment resistant depression not currently taking antidepressants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beckley Psytech Limited

Criteria

Inclusion Criteria:

1. Diagnosed with Major Depressive Disorder.

2. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments.

3. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.

4. Clinical Global Impression - Severity ≥4 at Screening.

5. Quick Inventory of Depressive Symptomatology - Self Rated - 16 item scale ≥13 at Screening.

6. Willing and able to discontinue current pharmacological anti-depressant therapy.

Exclusion Criteria:

1. Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.

2. Current personality disorders.

3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder.

4. Current alcohol or substance use disorder (other than caffeine or nicotine).

5. A participant who at any time, has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation.

6. Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.

7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.

8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.

9. Seizure disorder or history of seizures (including febrile seizures).

10. Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.

11. Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug.

12. Currently receiving lithium, antipsychotics, serotonergic drugs, psychostimulants, or any other prohibited medication.

13. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.

14. Male patients who are sexually active and not willing to using adequate forms of contraception.